Phase IIb trail results of epratuzumab in lupus patients to be presented at EULAR 2010

May 14 2010

Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that clinical trial results on epratuzumab, the anti-CD22 humanized monoclonal antibody licensed to UCB SA, Brussels, for autoimmune disease indications, from the Phase IIb study in patients with lupus, will be presented in four posters sessions and one published abstract. These presentations will occur at the 2010 annual Congress of the European League Against Rheumatism (EULAR), June 16 – 19, 2010, in Rome, Italy.  In the second half of 2010, UCB will initiate two Phase III studies of epratuzumab for the treatment of patients with moderate and severe lupus.

The schedule of the poster sessions, followed by key findings, are listed below:

• "Epratuzumab demonstrates clinically meaningful improvements in patients with moderate to severe systemic lupus erythematosus (SLE): Results from EMBLEM™, a Phase IIb study" [Saturday, June 19, 10:15 a.m. – 12:00 p.m.]

"Compared with placebo responder rate (21.1%), responder rates were statistically greater in epratuzumab 2400 mg (600 mg weekly) (45.9%;

•  "BILAG-measured improvement in moderately and severely affected body systems in patients with systemic lupus erythematosus (SLE) by epratuzumab: Results from EMBLEM™, a Phase IIb study" [Saturday, June 19, 10:15 a.m. – 12:00 p.m.]

"Treatment with epratuzumab 600 mg weekly during a 12-week cycle provided greater BILAG improvement over placebo in disease activity in all affected body systems. Efficacy was particularly prominent in cardiorespiratory and neuropsychiatric systems in which symptom improvements are often difficult to achieve."

• "The effects of the anti-CD22 monoclonal antibody epratuzumab on peripheral blood B cells and immune responses in vivo and immunoglobulin production in vitro" [Saturday, June 19, 10:15 a.m. – 12:00 p.m.]

"Epratuzumab treatment caused a reduction in B cells but had no effect on the capacity to raise antibody response to challenge antigens in Cynomolgus monkeys in vivo."

• "Impact of systemic lupus erythematosus on patients' employment, family relationships, and overall well-being" [Thursday, June 17 & Friday, June 18, 12:00 p.m. – 13:45 p.m., Saturday, June 19, 10:15 a.m. – 12:00 p.m.]

Also accepted for publication in the abstract book is "The effects of the anti-CD22 monoclonal antibody epratuzumab on B cell surface proteins". Topic: "03. Humoral aspects – autoantibodies".

"Epratuzumab stimulated rapid internalization of its target, CD22, on human peripheral blood B cells in vitro but had no consistent effect on a range of other B cell markers. This could lead to modulation of B cell functional responses that are regulated specifically by CD22, which may be relevant in the context of SLE."